MAUDE Adverse Event Report: TERUMO SURFLO; IV CATHETER

Model Number 22GX 1"

Device Problems Break (1069); Migration or Expulsion of Device (1395); Sticking (1597)

Patient Problems Anxiety (2328); Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2015

Event Type  Injury  

Event Description

Utilized a surflo iv catheter (22 gauge x 1 inch) made by terumo medical corporation, (b)(4), to sedate a (b)(6) female to remove a wisdom tooth (#16) that was preventing eruption of her second molar # 15 on the morning of (b)(6) 2015.The iv access was obtained in the right lateral acf, and it went in smoothly and flowed well throughout the procedure.Surgery was completed and pt recovered.As the pt was close to discharge, attempts by my staff to remove the iv were aborted as 3 different staff members felt that it was "stuck/held" by something so they summoned me to look.It was tethered in some way, and also i chose to spin the catheter in an attempt to remove it, and as i did, it seemed to release but in reality what happened was that the proximal 5-6 mm closest to the hub came out but left the greater portion of the catheter still in her vein (approx 18-20 mm).We immediately applied proximal pressure to try and prevent it from being carried centrally (to the heart and then the lungs).The pt became understandably anxious and began moving, so i chose to put a tourniquet on the proximal part of her right arm, and placed a new iv in her left arm and sedated her once again.Once she was quiet and still, i released the tourniquet (2-4 mins total), and had my staff apply proximal pressure again above the acf.I thought i could see the edge of the catheter in the site, so i locally anesthetized the site with lidocaine (1 carpule with epinephrine) and utilized a 15c blade to attempt to get enough access so that i could grab it with a mosquito forceps.It seemed like i was feeling it with the blade but i was unable to retrieve it so i opened the site vertically about 1 cm total.After a few mins of blunt exploration with the mosquito i could no longer confidently feel what i thought was the catheter.I felt that radiographic verification was going to be needed to localize the remaining catheter so we transported her via ems to our local emergency dept (ed) at (b)(6) (which was also her parent's choice).Once there, plain films of the arm and chest were unable to localize the catheter.I event brought an unused catheter of the same size and brand to use as a visual aid and used this as a "control" on her radiographs.An ultrasound was performed of the right arm proximal to the iv site and did not reveal the catheter either.A chest and arm ct was then performed.Although not initially seen on the initial reading of the exam, reformatted scans several mins later revealed that the catheter was lodged in an "ancillary" branch off of the right subclavian vein, and was not in the cardiac nor pulmonary system.The radiologist did not feel that it was within his skill level and/or worth the risk to try and retrieve the remaining catheter and suggested that a f/u examination with a pediatric cardiothoracic surgeon and/or pediatric interventional radiologist was the best next option.The pt was sedated for her procedure.She took 2 (0.25mg) halcion in the 90 mins prior to the surgery, was given 0.9% normal saline and then sedated with 50 micrograms of fentanyl, 2.5 milligrams of versed and 100 milligrams of propofol.She was also given 8 milligrams of dexamethasone and 4 mg of zofran, and was numbed with 2 carpules (3.4 cc) of 2% lidocaine with 1:100,000 epinephrine.She was later given another 2.5 mg of verses and 50 mg of ketalar once the catheter was broken and prior to attempting to retrieve it.

• Brand Name: SURFLO
• Type of Device: IV CATHETER
• Manufacturer (Section D): TERUMO; elkton MD 21921
• MDR Report Key: 4856394
• MDR Text Key: 5873204
• Report Number: MW5043151
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 22GX 1"
• Device Catalogue Number: SR*OX2225CA
• Device Lot Number: RF2727
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4 MG ZOFRAN; 2 (0.25MG) HALCION (IN THE 90 MINS); 0.9% NORMAL SALINE; 2.5 MG VERSED; 2 CARPULSES (3.4 CC) 2% LIDOCAINE; 100 MG PROPOFOL; 8 MG DEXAMETHASONE; 1:100,000 EPINEPHRINE; 50 MICROGRAMS FENTANYL; 50 MG KETALAR
• Patient Outcome(s): Hospitalization
• Patient Age: 10 YR
• Patient Weight: 48